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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transmitters and receivers, electrocardiograph, telephone
Product CodeDXH
Regulation Number 870.2920
Device Class 2


Premarket Reviews
ManufacturerDecision
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 6
CARDIOCOMM SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COALA LIFE AB
  SUBSTANTIALLY EQUIVALENT 1
ECORDUM, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIVMOR
  SUBSTANTIALLY EQUIVALENT 1
NANOWEAR INC.
  SUBSTANTIALLY EQUIVALENT 2
QT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
QT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG CORECARE TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VERILY LIFE SCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 3
VIVAQUANT INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 2 2
2022 6 6
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
False Negative Result 1 1
Communication or Transmission Problem 1 1
Application Program Problem 1 1
Smoking 1 1
Therapeutic or Diagnostic Output Failure 1 1
Thermal Decomposition of Device 1 1
False Alarm 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Detachment of Device or Device Component 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 3 3
Chest Pain 2 2
Myocardial Infarction 2 2
Dysphasia 1 1
Weight Changes 1 1
Shock from Patient Lead(s) 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Abdominal Distention 1 1
Atrial Fibrillation 1 1
Burn, Thermal 1 1
Cardiac Arrest 1 1
Neck Pain 1 1
Erythema 1 1
Pain 1 1
Tachycardia 1 1
Bruise/Contusion 1 1

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